Ophthalmologic insertor apparatus and methods of use

ABSTRACT

This invention discloses insertor devices that employ a flexible, deformable sleeve to house an implant. In one embodiment, a device is described that employs squeezing blades to advance an implant through the flexible sleeve into a passageway, tissue or cavity of the body. The invention further relates to holders for the sleeve to facilitate loading of an implant into the sleeve. In a preferred embodiment, the device is an insertor for a foldable lens and in particular the device is an insertor for the introduction of an intraocular lens into the eye. Methods for loading the devices of this invention with an implant, methods for making the sleeves of this invention and methods for use are discussed.

CROSS-RELATED APPLICATIONS

This is a continuation-in-part of U.S. patent application Ser. No.08/956,987, filed Oct. 24, 1997, now abandoned, which is incorporatedherein by reference.

FIELD OF THE INVENTION

The present invention relates to the field of implantation methods.Preferably, the invention relates to the field of ophthalmology and tothe use of medical devices in ophthalmologic surgery. In a particularlypreferred embodiment, the present invention relates to methods andprocedures for inserting implants into the eye.

BACKGROUND OF THE INVENTION

Artificial intraocular lenses are widely used to replace the humancrystalline lens of the eye. The human crystalline lens is a livingtransparent structure composed primarily of protein having a thicknessof about five millimeters and a diameter of about nine millimeters. Thelens is suspended behind the iris by zonula fibers that connect the lensto the ciliary body. A lens capsule surrounds the lens; the frontportion of the capsule generally referred to as the anterior capsule andthe back portion generally referred to as the posterior capsule.

The term “cataract” refers to the opacity of the lens of the eye. Thereare a variety of types of cataracts and for most cataracts, surgicalintervention is required to remove and replace the lens with anartificial intraocular lens.

The transparency of the lens depends on the physiochemical state of thelens proteins. These proteins, like the proteins of other organs, aresensitive to changes in the properties of their surrounding fluid.Changes in the concentration of dissolved salts, in the osmoticpressure, in the pH or in the enzyme activity of the surrounding fluidcan alter the properties of the lens proteins. Also, like other organs,changes to the proteins of the lens occur with age. A common type ofcataract that occurs in elderly people is known as a senile cataract.This type of cataract has no known etiology and none of the forms ofcataract produced experimentally to date closely resemble the senilecataract.

Artificial intraocular lenses generally comprise an optical region and asupport, or haptic, to facilitate positioning and centering of theintraocular lens within the eye. Intraocular lenses have been made froma number of different materials. For example, hard lenses have beenprepared from polymethylnethacrylate (PMMA) and optical glass whileflexible lenses have been prepared from silicone, polyHEMA(polyhydroxyethylmethymethacrylate), acrylics, collagen, andcombinations thereof. Flexible lenses have the advantage that they canbe folded or otherwise deformed prior to implantation to reduce theoverall size of the lens during the artificial lens implantationprocedure.

There are a number of procedures and devices that have been developedfor the removal of the natural lens followed by the insertion of anartificial lens. The extraction procedure can generally be categorizedas intracapsular (i.e., where the lens is removed together with the lenscapsule) or extracapsular (such as where a portion of the anteriorcapsule is circularly removed (capsulorhexis) and the posterior capsuleis left intact).

Presently, phacoemulsification is a widely used method for the removalof diseased or damaged natural lens tissue. The phacoemulsificationprocess generally employs a small incision typically of about 2millimeters (mm) to about 4 mm in length (but potentially as small as 1mm) through the cornea and a probe is used to ultrasonically break apartand remove the crystalline lens through the capsulorhexis.

There are a number of intraocular lens injectors that have beendescribed in the literature to position a deformable artificialintraocular lens in the eye. These injectors use an incision of about 2mm to about 4 mm, the incision size most frequently used in mostphacoemulsification procedures. A larger (about 4 mm to about 5 mm)capsulorhexis incision, also used in phacoemulsification procedures, isused to position the lens without requiring elongation of the incisionduring the injection process.

U.S. Pat. No. 4,681,102 to Bartell discloses one type of device toimplant an intraocular lens through a small incision. The injectorcomprises a load chamber that is used to fold a soft intraocular lensinto a shape having a smaller cross-sectional area than the originalunfolded cross-sectional dimension of the lens. The load chambercomprises two hinged members that together define a generallycylindrical lumen. Each of the two members includes a flange thatextends non-parallel to cylindrical members at a point of connection andpermits manipulation of the cylindrical members from a first openposition to a second closed position. The intraocular lens is insertedinto the load chamber when the two members are in an open position. Theflanges are advanced towards each other causing the two members to formthe generally cylindrical chamber. As the two members advance towardseach other, the intraocular lens that is inserted in the chamber iscompressed to conform to the generally cylindrical shape of the membersin the closed position. This device and those devices that include arigid chamber for deforming the lens can damage the lens during thedeformation process if the lens is not accurately and carefullypositioned in the chamber.

A number of patents use a pushrod (also described in these patents as apusher or piston-type device) to apply a force directly on a lens and topush the deformed lens from the device into the eye. For example, theloading chamber of Bartell (supra) is placed into a rigid injectorportion fitted with a pushrod. The pushrod pushes the intraocular lensthrough a generally circular lumen of the loading chamber and into aninjector nozzle. The pushing action of the pushrod can further damagethe lens material and haptics before the lens is positioned in the eye.

U.S. Pat. Nos. 4,702,244 and 4,573,998 to Mazzocco discloses a pushrodtype of device that functions similar to a plunger of a syringe toprovide a hydraulic force on a lens. The device includes a chamber forcontaining the intraocular lens in an unstressed state and for orientingthe lens in a prescribed orientation to facilitate lens placement withinthe eye. The plunger is used to exert a direct force on the lens or adirect force on liquid surrounding the lens, sufficient to deform thelens such that the optical zone is deformed to a substantially smallercross-sectional diameter than the optical zone in an unstressed state.The device includes a means to expel the lens from the device forplacement in the eye. The surgical device disclosed by Mazzocco requiresthe use of a direct force such as a hydraulic force or a pneumatic forceto move the lens from its unstressed stated into a deformed position. Inthe embodiment that compresses the lens from an unstressed state to astressed state, the lens is propelled toward a small opening at the endof a holding tube. As the lens approaches the opening it is folded backagainst itself and compressed to fit through the opening. Theorientation of the lens in the device is not uniform, nor woulddeformation be consistent with each injection. Moreover, the hydraulicforce would likely be quite high and this pressure is likely notpractical for use in the internal aspects of the eye.

U.S. Pat. No. 5,468,246 to Blake discloses another type of intraocularlens injector that compresses the diameter of the intraocular lens byrolling the lens into a tight cylindrical tube that can be inserted intothe eye through a small incision of about 2 millimeters to about 4millimeters. This device also uses a pushrod-type device to apply adirect force to move the lens from the injector device into the eye.

U.S. Pat. No. 5,562,676 to Brady, U.S. Pat. No. 5,275,604 to Rheinish,U.S. Pat. No. 5,474,562 to Orchowski, U.S. Pat. No. 4,919,150 to Stoy,U.S. Pat. No. 5,123,905 to Kelman and U.S. Pat. No. 5,616,148 to Eaglesuse an injector with a tapered or conical loading chamber to guide andfold the lens into a rigid lumen. These patents also use a pushrod toinject the lens from the lumen into the eye. A problem with theseinjectors is that the internally positioned pushrod is in direct contactwith the lens assembly. This direct contact can result in distortion,bending or breakage of a trailing haptic. In addition, compressiveforces on soft or fragile lens materials can tear the lens or destroy ahaptic. In addition, during compression, the pushrod can catch or wedgea portion of the lens between the rigid lumen of the device and thepushrod mechanism.

There remains a need for a device for introducing a flexible implant,particularly fragile foldable lenses into the body without damaging thatimplant. In particular, there is a need for a device to implant afoldable intraocular lens into an eye without damaging the lens or thehaptics during the implantation process.

SUMMARY OF THE INVENTION

This invention discloses insertor devices that employ a flexiblecompressible sleeve to deliver an impant into the body. In a firstaspect of this invention, the invention relates to a flexiblecompressible sleeve comprising a first opening and a second opening witha lumen extending through the sleeve, wherein the size of the firstopening is greater than the size of the second opening and wherein thethickness of a wall of the first opening is thinner than the thicknessof a wall of the second opening. In one embodiment, the sleeve has alength of about 10 mm to about 50 mm. In another embodiment the width ofthe sleeve is about 1.5 mm to about 4 mm at the second opening.Preferably, the thickness of a wall of the first opening is about 0.01mm to about 0.1 mm. and the thickness of a wall of the second opening isabout 1.5 mm to about 3.5 mm. Still more preferably, the sleeve isdistendable.

In another apsect of this invention, the invention relates to aflexible, compressible sleeve wherein the sleeve comprises a firstopening and a second opening and a lumen extending through the sleeve,wherein the sleeve is prepared from a non-opaque material and whereinthe width of the first opening is larger than the width of the secondopening.

The invention also relates to a system for loading an implantcomprising: a flexible, compressible sleeve wherein the sleeve comprisesa first opening and a second opening and a lumen extending through thesleeve, wherein the sleeve is prepared from a non-opaque material andwherein the width of the first opening is larger than the width of thesecond opening; and a sleeve holder prepared from a substantially rigidmaterial and comprising a lumen extending therethrough, wherein thelumen comprises a first opening and a second opening and wherein thefirst opening is larger than the second opening and wherein the lumen isadapted to substantially conform to the shape of the sleeve.

In a further aspect of this invention, the invention relates to a sleevesupporting device comprising a substantially rigid body comprising alumen extending therethrough, wherein the lumen comprises a firstopening and a second opening and wherein the first opening is largerthan the second opening and wherein the lumen is adapted tosubstantially conform to the shape of a sleeve. Preferably the width ofthe first opening is from about 4.5 mm to about 10 mm and the width ofthe second opening is from about 1.5 mm to about 4 mm.

The invention relates to a kit comprising: a flexible, compressiblesleeve wherein the sleeve comprises a first opening and a second openingand a lumen extending through the sleeve, wherein the sleeve is preparedfrom a non-opaque material and wherein the width of the first opening islarger than the width of the second opening; and an implant. Optionally,the kit can further comprise a sleeve holder prepared from asubstantially rigid material and comprising a lumen extendingtherethrough, wherein the lumen comprises a first opening and a secondopening and wherein the first opening is larger than the second openingand wherein the lumen is adapted to substantially conform to the shapeof the sleeve. In one embodiment, the implant is a flexible lens.

In another aspect of the invention, the invention relates to a devicefor introducing an implant into the body comprising: a flexiblecompressible sleeve wherein the sleeve comprises a first opening and asecond opening and a lumen extending through the sleeve, wherein thesleeve is prepared from a non-opaque material and wherein the width ofthe first opening is larger than the width of the second opening; and ahand-piece capable of mobilizing the implant and immobilizng the sleeve.In one embodiment, the implant is a lens and preferably an intraocularlens. In one embodiment, the hand-piece comprises at least one blade tomobilize the implant by squeezing the sleeve and in another thehand-piece comprises a pushrod positioned within the sleeve to mobilizethe implant. In a preferred embodiment, the hand-piece further comprisesa pressure fit element to immobilize the sleeve in the hand-piece andpreferred pressure fit elements include a collet or a screw

The invention also relates to device for introducing a flexible implantinto a portion of the body comprising: a compressible, flexible sleevecomprising a flexible polymeric material and a lumen extending throughthe sleeve; an implant positioned in the sleeve; and a hand-piecewherein the hand-piece further comprises a push-rod that extends intothe sleeve. Preferably the the sleeve has a first opening and a secondopening and wherein the width of the first opening is larger than thewidth of the second opening and preferably the push rod has a roundedtip.

In another aspect of this invention, a method is disclosed for preparinga flexible, non-opaque sleeve comprising the steps of: positioning aflexible, compressible, deformable tubing in a press wherein the presscomprises at least two compressive surfaces; applying a compressiveforce to the tubing to permanently distend at least a portion of thetubing and to form a distended portion of the tubing and a non-distendedportion of the tubing; cutting the tubing in the distended portion andcutting the tubing in the nondistended portion to form a sleeve. In apreferred embodiment, the tubing is a polymeric tubing and in apreferred embodiment the tubing is PTFE or ETFE. In one embodiment thepress is a cold press and in another embodiment, the press furthercomprises heat. In a preferred embodiment the thickness of the wall ofthe distended tubing is at less than two-thirds of the thickness of thetubing before applying the compressive force.

The invention also relates to an intraocular lens insertor, theimprovement comprising the use of a flexible, compressible immobilizedsleeve housing an intraocular lens wherein the lens is positioned in thesleeve before the sleeve is immobilized in the insertor.

In another embodiment the invention is a device for introducing animplant into the body comprising; a flexible compressible sleeve whereinthe sleeve comprises a first opening and a second opening and a lumenextending through the sleeve, wherein the sleeve is prepared from anon-opaque material and wherein the width of the first opening is largerthan the width of the second opening; an implant; and a hand-piececomprising a pushrod to fit within the flexible sleeve and means foradvancing the pushrod to mobilize the implant in the device. Preferablythe sleeve is tapered from the first opening to the second opening andpreferably the thickness of a wall of the first opening of the sleeve isless than two-thirds of the thickness of a wall of the second opening ofthe sleeve. In one embodiment, the implant is a lens and in a preferredlens embodiment, the lens is an intraocular lens.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded perspective view of a preferred lens insertor ofthe present invention. FIG. 1a is a perspective view of a collet andFIG. 1b is a cross-section through the collet at G—G as illustrated inFIG. 1.

FIG. 2 illustrates a preferred sleeve embodiment and a squeezing toolaccording to this invention.

FIG. 3 illustrates a series of cross-sectional configurations of atleast the tapered portion of the sleeve of this invention. FIG. 3aillustrates a circular cross-section; FIG. 3b, an ellipticalcross-section; FIG. 3c, a flattened cross-section; FIG. 3d, an envelopedcross-section; FIG. 3e, a pleated cross-section; FIG. 3f, a plurality ofpleats in cross-section; FIG. 3g, a “V” shaped cross-section.

FIGS. 4(a) through 4(e) are cross-sectional views of the distal portionof a collet from the device of FIG. 1. FIG. 4a illustrates a roundconfiguration; FIG. 4b, a rhomboid configuration; FIG. 4c, a wingedcircular configuration; FIG. 4d, an expanded winged circularconfiguration; FIG. 4e, another embodiment of an expanded wingedcircular configuration; and FIG. 4f, a scrolled configuration.

FIG. 5a is a cross-sectional view of a multi-piece sleeve according tothis invention. FIG. 5b illustrates a multi-piece sleeve followingseparation of the sleeve.

FIG. 6 is a cross-sectional view of an assembled insertor deviceaccording to FIG. 1.

FIG. 7 is a cross-sectional view of the assembled insertor device ofFIG. 6 rotated 90°.

FIG. 8 is a perspective view of the distal portion of an assembledinsertor device according to this invention.

FIG. 9 is a cross-sectional view of a lens preassembled in a sleeve.

FIG. 10a is a cross-section of a front-loading device according to thisinvention with a front-loading sleeve. FIG. 10b is a view of the frontloading device with a squeezing tool.

FIG. 11 is an illustration of a preassembled insertor according to thepresent invention illustrating a multi-step pushing mechanism. FIG. 11aillustrates the preassembled insertor. FIG. 11b illustrates a first stepin the pushing mechanism and FIG. 11c illustrates a second step in thepushing mechanism.

FIG. 12 is another embodiment of a lens insertor of this inventionillustrating external bending guides. FIG. 12b provides a cross-sectionthrough the insertor to illustrate the external bending guides.

FIG. 13 is another embodiment of an insertor according to thisinvention.

FIG. 14a is a cross-sectional view of the eye with a device according tothis invention inserting a foldable intraocular lens. FIG. 14b is across-sectional view of an eye receiving an implantable contact lensusing a device of this invention.

FIG. 15 is an enlarged partial cross-sectional view of the interfacebetween a preferred means for compressing a sleeve in accordance withthe present invention.

FIG. 16a is a perspective view of a sleeve with an intraocular lens forinsertion into a collet. FIG. 16b is a view of an assembled sleeve andcollet. FIG. 16c illustrates assembly of a ring clamp onto the colletand FIG. 16d illustrates an assembled sleeve in a collet positioned witha ring clamp.

FIG. 17a is a perspective view of an assembled sleeve, collet and ringclamp positioned onto a hand-piece with blades. FIG. 17b is aperspective view of the assembled device of FIG. 17a. FIG. 17c is across-section through lines D—D illustrating the position of bladesaround the sleeve within the lumen of the collet.

FIG. 18a is a perspective view of an assembled sleeve, collet and ringclamp positioned onto a hand-piece with a push-rod. FIG. 18b is aperspective view of the assembled device of FIG. 18a. FIG. 18c is across-section through lines E—E illustrating the position of thepush-rod in the sleeve within the lumen of the collet.

FIG. 19 is a perspective view of a preferred sleeve holder of thisinvention.

FIG. 20 illustrates a preferred method of this invention for preparing asleeve.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention provides a novel device for the introduction of avariety of implantable devices, preferably lenses, such as anintraocular lens, into the eye. The invention also relates to the use ofa flexible and distendable sleeve to house a flexible implant duringintroduction of the implant into the body. In contrast to otherimplantation devices currently available, one embodiment of thisinvention applies off-axis an external squeezing force on a flexible,distendable sleeve containing an implant to gently urge the implantthrough the sleeve, from the device and into the body. Other devices forthe implantation of intraocular lenses currently apply a direct forcesuch as through a compressive pushrod, also referred to as a pusher orpiston, that directly contacts the lens to inject the lens into the eye.In a preferred application of the present invention, the device isuseful for the introduction of a lens into the eye and in particular,for the introduction of an intraocular lens through an incision in theocular tissue, such as the incisions employed using aphacoemulsification cataract removal procedure.

The devices of this invention are insertion devices. That is, the term“insertor” is used herein to refer to a device that places an implantinto a passageway, cavity or tissue of the body. In one embodiment ofthis invention, the insertors of this invention use an off-axis orindirect force to advance the implant into the body.

The devices of this invention are useful for inserting a variety ofitems in the eye. For example, in a preferred device, the device is usedto insert an intraocular lens into the eye. Modifications of the devicepermit the design of a variety of devices suited for insertion of avariety of lenses or implants into the eye including, but not limitedto, a posterior and anterior intraocular lens, a corneal inlay lensinserted into the cornea of the eye, either as an inlay or as a cornealrefractive implantable contact lens (ICL), a scleral buckle implant, tointroduce a contact lens onto the eye, to introduce an artificial ductor implant material including tubing, and the like into the eye to shuntfluid from the anterior chamber of the eye such as for glaucoma surgery.The devices of this invention can be used to position an implantelsewhere in the body. For example, to introduce subcutaneous orintramuscular implants, including sustained drug release devices, or ascatheter-like devices, and the like. While the present invention isdescribed by way of its ability to introduce an intraocular lens orother lenses into an eye, those of ordinary skill in the art willrecognize that a variety of implantable items can be introduced into avariety of positions in the body through devices as described in thisinvention.

The term “proximal” is used herein to refer to that portion of thedevice or element of the device that is closest to the physicians fingerthat is being used to activate the pusher element of the devices of thisinvention. The term “distal” is used herein to refer to that portion ofthe device or element of the device that is farthest from thephysician's finger that is being used to activate the pusher element ofthe devices of this invention.

The term “squeezing” is used herein to refer to a compressive off-axisforce applied behind an object to mobilize the object ahead of theoff-axis force along a defined course. The compressible force includes acomponent transverse to the longitudinal axis of the device, where thelongitudinal axis is defined by the direction of movement of the implantbeing inserted.

The term “soft implant” is used herein to refer to a malleable, ductile,compressible elastic, rubbery or gelatinous substance having a readingon an A durometer of generally about 20 A to about 70 A, but could be aslow as 5 A for a hydrophillic contact lens or about 90 A for a flexibleacrylic material. Durometer instruments are available from PacificTransducer Corp., Los Angeles, Calif.

The term “flexible and compressible” sleeve refers to sleeves preparedfrom a variety of flexible materials, including flexible polymericmaterials, such as those that can be generally measured on a D scale oran A scale, and preferably materials having a D durometer reading fromabout 40 D to about 80 D. Other hardness scales can also be used. Ingeneral, durometer testers and their methods of use are described inASTM D-2240. The “A” scale can be used, for example, to measure theflexibility or relative hardness of synthetic rubbers, neoprene,silicones, felt, and the like. The “B” scale can be used to measure theflexibility or alternatively the relative hardness of a variety ofrubbers and elastomers. The “C” scale is used to measure medium hardrubbers and plastics. The “D” scale is used to measure a variety ofplastics, plexiglass, polystyrene, vinyls, and the like. The “OO” scalecan be used to measure the hardness of materials such as sponges, rubberor soft rubber. Those of ordinary skill in the art will recognize thatthe materials need be readily compressible by the blades of the devicesof this invention and therefore, a variety of materials used toconstruct objects to be inserted as an implant are considered “flexibleand compressible” and preferably malleable for purposes of thisdisclosure, particularly in view of exemplary sleeve materials suppliedlater in this disclosure.

The term “pleat” as used in this invention refers to one or more foldsor creases present in all or a portion, preferably at least the taperedportion, of a sleeve of this invention.

FIG. 1 is a preferred embodiment of the present invention for insertinga lens into the eye of a patient. The exploded view of insertor 10provides a hand-piece 12, including a pusher element 14 capable ofengaging at least one push-blade 16, a collet 18 capable of receiving acompressible sleeve 20 and a ring clamp 22 to secure the collet 18 tohand-piece 12.

Sleeve 20 is prepared from a compressible, flexible, deformable andsmooth material, preferably a flexible polymeric material such asethylene tetrafluoroethylene (ETFE, Zeus Corp. Orangeburg. S.C.), butother materials can be used, including, but not limited to: othertetrafluoroethylenes (e.g., polytetrafluoroethylene (PTFE), fluorinatedethylenepropylene, perfluoroalkoxyfluoro-carbons, flexible vinyls (e.g.,polyvinyl chloride or polyvinylide fluoride), polyimide, polyamide,polyester, silicones, polyolefin materials, non-opaque TEFLON, polyvinylchloride with a hardness range of about 35 D to about 80 D, etc.Preferred materials are sufficiently non-opaque that an implant can beseen in the sleeve when positioned therein. Sleeve 20 is preferablyformed from a flexible, deformable and compressible tubing (e.g., ETFEor PTFE tubing) that is preferably malleable and capable of beingpressed or distended. Alternatively, the sleeve can be injection molded.The sleeve 20 can be coated on its interior or exterior surfaces with avariety of friction reducing materials to ease the passage of a lensthrough the length of the sleeve 20. The coatings can, for example,reduce friction on the lens by the sleeve. Preferred coating materialsinclude, but are not limited to, silicones, such as HYDRO-SIL (TUASystems, Sarasota, Fla.), ion-exchange hydrophilic treatments such asHYDRO-SILK or other coatings including, but not limited to, heparin,PARYLENE (Nova Tran Corp., Clear Lake, Wis.), or NOVA TRAN (Nova TranCorp), etc.

Referring now to FIG. 2, sleeve 20 preferably includes a first opening24 capable of receiving an intraocular lens. In one embodiment, firstopening 24 (proximal portion of sleeve) has a width that is sufficientto receive an unfolded or substantially unfolded lens; however the firstopening 24 can be small enough to require some deformation of the lens.Typically for intraocular lens implantation, first opening 24 ispreferably at least about 1.5 millimeters (mm) in width and preferablyless than about 10 mm in width and preferably for an intraocular lensinsertor, greater than about 3 mm and less than about 9 mm in width. Thewalls of the material used to prepare sleeve 20 can be a variety ofthicknesses provided that the sleeve 20 remains readily compressible by,for example, blades 16, maintains its integrity during use and issufficiently deformable to permit positioning of an intraocular lenswithin the sleeve.

The first opening 24 of the sleeve can have any of a variety ofconfigurations including, but not limited to, straight edges, such asprovided in FIG. 2, chamfered edges, curved edges, either concave orconvex curves relative to the tip of the sleeve. Alternatively, thefirst opening 24 of the sleeve can be angled.

Sleeve 20 also includes a second opening 26 in the tubular portion ofthe sleeve and the width of sleeve 20 preferably decreases over at leasta portion of the sleeve from first opening 24 to second opening 26 toprovide a tapered portion 28 to sleeve 20. In a preferred embodiment,the taper of sleeve 20 preferably reduces the dimension of the sleevefrom the first opening 24 to the second opening 26 within one-half ofthe length of the sleeve. The tapered portion 28 reduces the width ofthe sleeve toward the distal portion of the sleeve. For the intraocularlens embodiment, second opening 26 is at least about 1 mm in diameterand preferably less than about 4 mm in diameter with preferreddimensions for an intraocular lens insertor of between about 2 mm toabout 2.5 mm for soft flexible lenses and as much as 4 mm for lessflexible lenses such as acrylic lenses.

Preferably, the length of sleeve 20 is preferably at least about 1 cmand more preferably at least about 2 cm, for the intraocular lensembodiment, the sleeve is at least about 5 cm and typically, the sleeve20 will be less than about 10 cm in length. In a preferred embodiment ofan intraocular lens insertor, the length of sleeve 20 is preferablygreater than about 2.5 cm and less than about 3 cm. For the frontloading device, discussed below, the sleeve can be about 5 cm. Althoughlonger or shorter sleeve lengths can be adapted to longer or shorterdevices. Second opening 26 is preferably beveled, from about 16° toabout 75° much like the tip of a needle to ease insertion of the implantinto the eye, although a variety of configurations to second opening 26are possible. The second opening 26 of sleeve 20 can take on a varietyof other shapes and in one embodiment the second opening 26 is ellipsoidor circular in cross-section. Optionally, second opening 26 of sleeve 20can be tapered or can be flared.

In a preferred sleeve embodiment, illustrated in FIG. 3, thecross-section of the sleeve 20 can have a variety of configurations. Ina preferred embodiment, the tapered portion 28 of sleeve 20 can have anyone of the configurations provided in FIG. 3. FIG. 3a illustrates acircular cross-section 30; FIG. 3b, an elliptical cross-section 32; FIG.3c, a flattened cross-section 36; FIG. 3d, an enveloped cross-section34; FIG. 3e, a pleated cross-section 38; FIG. 3f, a plurality of pleatsin cross-section 40; FIG. 3g a “V” shaped configuration incross-section, or a combination thereof. Those skilled in the art willappreciate that there are a number of other cross-sectionalconfigurations that are possible.

In one embodiment, the tapered portion 28 of sleeve 20 is pleated 38(see FIG. 2) for at least a portion of its length and preferably thetapered portion 28 of sleeve 20 is pleated while the distal portion ofsleeve 20 is generally circular in cross-section but could be ovoid orflattened. The cross-sectional configurations of the sleeve 20 can serveas guides to promote folding of the implant, such as a lens in a sleeve.In addition, the shape of the sleeve 20 at the first opening 24 of thesleeve can vary and could be flattened, ellipsoid, ovoid, enveloped,pleated, or the like. Moreover, the cross-sectional configuration ofsleeve 20 can vary from first opening 24 through tapered portion 28 tosecond opening 26. For example, the cross-section at first opening 24can be ovoid, while the tapered portion is pleated and the portion ofthe sleeve adjacent to second opening 26 can be circular incross-section. Pleats are not necessary and in the embodiments using asleeve holder (infra), pleats are optional.

Sleeve 20 of FIG. 2 is illustrated as a single piece sleeve, that is acompletely integral object. However, it is also contemplated that thesleeve 20 can be constructed from two or more pieces to form amulti-piece sleeve. FIGS. 5a and 5 b illustrate a preferred embodimentof a multi-piece sleeve. The sleeve 21 comprises a first opening 25 atthe proximal portion of the sleeve, a second opening 27, with a beveledtip, at the distal portion of the sleeve and a tapered portion 29 withthe connection 31 between the two pieces preferably positioned justdistal to the tapered portion 29. The sleeve pieces can be used as anintact sleeve or the portion of the sleeve including the first opening25 can be discarded while that portion of the sleeve including thesecond opening 27 and the lens 50 can be used separately. Alternatively,a lens in a uniformly tubular sleeve can also be employed, such as thatportion of the sleeve with opening 27 illustrated in FIG. 5b. Themulti-piece lens can be used, for example, with the front loading deviceof FIG. 9, as described below.

In one embodiment, both proximal and distal portions of the sleeve areprepared from ETFE, PTFE, or the like, and in another embodiment thatpart of the sleeve including second opening 27 is prepared from ETFE orPTFE while that portion of the sleeve including first opening 25 cancomprise an elastic portion such as a soft silicone, an elastomericlatex, or another flexible material. Alternatively, the multi-piecesleeve can be prepared from materials with different hardnesses. In oneexample, that portion of the sleeve including first opening 25 can beprepared from a flexible, deformable material while that part of thesleeve including second opening 27 can be more rigid. Where the sleeve21 is provided as a multi-piece sleeve, preferably the portions of thesleeve are affixed to each other by any suitable method or materialincluding, but not limited to, an epoxy bond, a heat bond, siliconeadhesive, acrylic adhesive, welding (e.g., ultrasonic, laser, etc.).

The sleeves of this invention are compressible, deformable andpreferably flexible and malleable. The sleeves protect the implant fromdamage and provide a cost effective delivery system for introducing animplant into the body. Preferred dimensions of the sleeve at thenarrower end (the second opening or tubular portion of the sleeve) ispreferably 1.5 mm to about 4.0 mm in diameter and the preferred lengthof the sleeve is from about 10 mm to about 50 mm depending on theparticular application of the insertor apparatus. The thickness of thewall of the first opening is preferably about 0.01 mm to about 0.1 mm.The thickness of the wall of the second opening is preferably about 0.15mm to about 0.35 mm. Preferably the tubular portion of the wall isconstant from the second opening to the distal end of the taperedportion. This disclosure includes a number of variations that all employthe sleeves of this invention. Those of ordinary skill in the art willrecognize that the sleeves of this invention can further be incorporatedinto a variety of implantation devices including, but not limited to,intraocular lens inserters and injectors.

The hand-piece, pusher element, collet and ring clamp can be preparedfrom a variety of durable, stiff materials such as hard plastics,including moldable plastics, acrylics, styrene, clear, opaque ornon-opaque materials. Those with ordinary skill in the art willappreciate the advantages of a non-opaque collet, for example, thatpermits the continued viewing of the lens during insertion. Hand-piece12 and other hand-pieces of this invention can further be prepared fromstainless steel, polysulfone, polycarbonates, nylons, acetals or othersuitable materials with or without glass, carbon or graphite fillers.The pieces can be prepared from heat or irradiation-stable materials forreuse or prepared as a disposable for single-use applications.

The sleeves of this invention are preferably disposable, and asdiscussed further below, the sleeves can be supplied with or without animplant. Where the sleeves of this invention are reused, care is takento monitor wear of the sleeve and preferably, the sleeves are treatedfor microbial contamination before reuse.

Referring again to FIG. 1, the device 10 includes a collet 18 to engagesleeve 20 and maintain orientation of sleeve 20 in the device. Collet 18is substantially hollow to form an internal lumen 47 (FIG. 1b) andcomprises a proximal end 42 and a distal portion 46. Collet 18 ispreferably slightly tapered down its length and in a preferredembodiment, collet 18 includes at least two slits 43 (see FIG. 1a) forimmobilizing the sleeve in the device and a notched portion 49, or othermeans, for engaging hand-piece 12 and preventing rotation of hand-piece12 relative to collet 18 during use. Those of ordinary skill in the artwill recognize that there are a variety of modifications to the collet,hand-piece or ring-clamp that could be used to immobilize the sleeve ofthis invention and that, for purposes of this invention, an immobilizedsleeve is an important and preferred aspect of this invention.

In a preferred embodiment, the internal lumen 47 of the collet 18 taperstoward the distal portion 46 of collet 18 to guide blades 16 toward theimplant and to permit the blades to track smoothly as they advance theimplant toward second opening 26 of sleeve 20. FIG. 4 provides a numberof cross-sectional views looking down the length of collet 18 from thedistal portion 46 and including lumen 47. The distal portion 46 ofcollet 18 can take on any of a variety of cross-sectional configurationsas illustrated in FIG. 4. FIG. 4a illustrates a round configuration;FIG. 4b a rhomboid configuration; FIG. 4c a winged circularconfiguration; FIG. 4d an expanded winged circular configuration; FIG.4e an even more expanded winged circular configuration; and FIG. 4f ascrolled configuration. Two edges of the rhombus (FIG. 4b) and thewinged portions by cross-section (FIGS. 4c-4 f) are available as guidesfor blades 16.

In addition to the modifications to the distal portion of the internalsurface of collet 18 (FIG. 4), the internal surfaces of the lumen formedin collet 18 can be modified in other ways. For example, lumen 47 can bemodified as illustrated in cross-section G—G through collet 18 (see FIG.1b). This shape provides guidance and lateral stability to blades 16.Alternatively, modifications to the internal surfaces of the collet orwhere a collet is not used, the internal surface of the hand-piece caninclude guides such as those provided in FIG. 11 or follow those ofRheinish et al. (U.S. Pat. No. 5,275,604). Further, the cross-sectionaldimension of the internal lumen of the collet also preferably narrowsfrom the proximal portion toward the distal portion of the collet 18 topermit blades 16 to track smoothly into contact with sleeve 20 whensleeve 20 is loaded into device 10. Importantly, the guides arepositioned outside of the flexible sleeve and therefore do not contactthe implant directly.

Hand-piece 12 (FIG. 1) includes an elongate shaft preferably with aflange 45 at its proximal portion and threads 47 at its distal portion.Hand-piece 12 is preferably substantially hollow and is adapted toreceive pusher 14. Distal portion 48 (see FIG. 7) of hand-piece 12 ispreferably adapted to receive notched portion 49 of collet 18. Distalportion 48 is also preferably threaded to receive ring clamp 22.Optionally hand-piece 12 also includes grips such as longitudinalgrooves or roughened portions along its length to prevent sliding andunwanted rotational movement during use.

Pusher element 14 is preferably an extended rod that is adapted to fitwithin the hollow portion of hand-piece 12 and to mate in contour withhand-piece 12. Pusher element 14 preferably includes a broadenedproximal portion 51 to facilitate movement of the pusher element 14relative to hand-piece 12. Optionally, guides or ridges on the outersurface of pusher element 14 can be added to mate with matchingreceiving guides within the hollowed portion of hand-piece 12.

Preferably the device 10 is equipped with at least two blades 16 affixedto the distal portion of pusher element 14. The blades 16 can beprepared from a variety of materials including, but not limited to,TEFLON, plastic, metal-reinforced plastic, stainless steel or otherrigid materials. In a preferred embodiment, blades 16 are prepared fromstainless steel wire, such as hard spring temper type 302 stainlesssteel wire rolled flat having a tensile strength of about 280,000 psi ortype 17-7 precipitation hardening (PH) stainless steel drawn wire rolledflat and then heat treated to 240,000 psi in a vacuum or as much as320,000 psi (Supreme Steel Treating Inc., El Monte, Calif.). However,steel wire greater than about 60,000 psi is also considered suitable forthe blades of this invention. Those of ordinary skill in the art willrecognize that the rigidity of the blade is a function of the type ofmaterial, the length of the blade and the thickness of the blade andthat the selection of the material will also take into account the typeof implant to be inserted into a portion of the body. Some plastics canbe used, but plastic blades may be thicker than steel blades to providesufficient rigidity to the blades.

In a preferred embodiment, using two blades for lens insertion, theblades 16 are at least 1 centimeter (cm) in length and preferably lessthan about 10 cm in length. For an intraocular lens embodiment, theblades are preferably greater than about 3.5 cm and preferably less thanabout 6 cm in length and more preferably less than about 4.5 cm inlength. Also preferably, each blade is preferably at least about 1 mm inwidth and preferably less than about 10 mm in width. The length that thesleeve is selected to extend beyond collet 18 can vary and the length ofblades 16 will vary with this length. Also preferably, each blade is atleast about 0.25 mm in thickness and preferably less than about 1.5 mmin thickness. However, blades of as thin as 0.1 mm could function in asmall, compact insertor.

In a preferred embodiment, the blades 16 are formed such that the tipsof the blades bend slightly together. Those skilled in the art willrecognize that the extent of the bend in the blades can be variedsomewhat, particularly depending on the overall dimensions of thedevice. For example, the blades can be bent or curved in a slight archor curved or bent slightly inward toward each other at one or morelocations along the length of the blades. For example, blades can becurved inwardly from about 1 mm to about 10 mm relative to the planeformed by the blade. Alternatively, the tip of the blade can be bentslightly such as from about 0.02 mm to about 0.2 mm relative to theplane formed by the blade. Blades 16 can be polished, as needed, tofurther reduce friction of the blades either in the hand-piece 12, thecollet 18, or on sleeve 20. The blades can be affixed to the pusherelement using adhesives, crimping, pinning or a variety of means knownto those of ordinary skill in the art.

While the invention has been disclosed by way of the use of two blades,those of ordinary skill in the art will appreciate that a number ofblades can be used. For example, it is possible to employ a singleimmobilized blade, prepared as a blade or as a portion of the collet,together with a single movable blade to apply an off-set force thatsqueezes the sleeve at a point proximal to the implant to advance theimplant toward the distal portion of the sleeve. Alternatively, thedevice could employ three, four, or more blades positionedconcentrically around the sleeve. Also alternatively, a single flatblade could move or alternatively be immobilized and two smaller bladescould assist in advancing the implant through the device using thepusher 14. Further, rather than a blade, a solid ring or cylinder fittedover the sleeve can be used in place of one or more blades to advance animplant down a sleeve. The blades can also be fitted with guide groovesor ridges to assist in the axial tracking of the blades through thedevice.

In a preferred embodiment, illustrated in FIG. 1, the blades aresubstantially flat, however; those of ordinary skill in the art willalso appreciate that the blades can be wider and flattened to a greaterdegree than the blades illustrated in FIG. 1. Alternatively, the bladescan be cylindrical in shape, curved or ovoid. Again, the shape, widthand thickness of the blade can be selected based on the type of implant,the dimensions of the implant, as well as the choice of blade material.Preferably, care is taken so that the edges of the blades are smooth anddo not tear or substantially deform the sleeve during use.

Alternatively, the blades 16 can be configured similar to the blades ofa tweezer. In yet another embodiment of this invention, blades 16 canalso be encased in a layer of protective material, such as a layer oftubing, or an external, preferably transparent sheath, such as aseparate flexible sheath or multiple lumen tubing, or a sleeve where atleast the inner lumen containing the implant is compressible andflexible and where the blades are encased each in their own coveringwithin a second lumen that encompasses both the sleeve and the blades.Alternatively, the second lumen can be prepared from a rigid material toenclose the blades as they advance the implant, for example, such aswhere the blades do not extend beyond the distal portion of the handpiece.

The squeezing action of a blade or blades on a flexible and compressiblesleeve containing one or more implants produces a controlled anddeliberate movement of the implant through the sleeve along apredetermined axis of motion, defined by the sleeve, and at a controlledrate. The blades provide a means for compressing a sleeve and a meansfor advancing the compressed area of the sleeve toward the distal end ofthe sleeve. Those of ordinary skill in the art will recognize that othermechanisms employing these means can be incorporated into the devices ofthis invention. Those of ordinary skill in the art will recognize thatforces on the flexible and compressible sleeve from the blade(s) and thefrictional forces between the sleeve and the implant can be increased ordecreased to maximize controlled movement of the implant through thedevice and into the body.

Device 10 also includes a ring clamp 22 adapted to fit over collet 18and to secure onto hand-piece 12. Ring clamp 22 further compresses thesides of collet 18 to squeeze clamp the sleeve 20 within the collet 18during use. Those of ordinary skill in the art will recognize that thering clamp is not necessary and that device can be configured to securethe collet or its equivalent to the pusher element and to immobilize thesleeve in a variety of ways. Alternatively, the collet can be includedas part of the hand-piece, such as for example, in the front-loadingdevice discussed below.

Optionally a stopping mechanism, such as a stop bar or a key ispositioned along the length of the hand-piece to mate with an extensionon the pusher. A stop bar or key can be used to stop the blades and thepusher element from pulling out of the hand-piece or extending furtherthan desired from the distal end of the collet. A key 214 is used inFIG. 11.

To assemble device 10, a sleeve 20, preferably containing a lens 50 (seeFIG. 1) between second opening 26 and tapered portion 28 (i.e.,preferably substantially within the tubular portion of the sleeve) isintroduced into lumen 47 of collet 18. Referring again to FIG. 1,illustrating a preferred view of the proximal portion of collet 18 bycross-section. That portion of the sleeve 20 with second opening 26 isintroduced into the length of collet 18 such that first opening 24 ofsleeve 20 is positioned within the proximal portion of collet 18 and ispositioned between slits 44 but preferably does not extend beyond slits44 past the dimension of collet 18. Second opening 26 of sleeve 20preferably extends beyond the distal portion of collet 18. Pusherelement 14 with blades 16 is then introduced into hand-piece 12. Next,blades 16 are positioned on either side of sleeve 20 and moved towardthe distal portion of the collet 18 preferably until resistance is felton the blades due to the contact between blades 16 and that portion ofsleeve 20 containing lens 50. Collet 18 is next positioned onto thedistal portion of band-piece 12, preferably mating notch 49 on collet 18with a groove on hand-piece 12. Ring clamp 22 is positioned over sleeve20 and around collet 18 and is securely engaged onto the distal portionof hand-piece 12. In use, pusher element 14 is pushed forward to moveblades 16 down the length of sleeve 20 to gently urge lens 50 out ofsleeve 20.

FIG. 6 provides a cross-sectional view of the assembled device 10 incross-section and FIG. 7 provides a second cross-sectional view of theassembled device rotated 90° relative to FIG. 6. Here, sleeve 20contains a lens 50. The proximal portion containing first opening 24 ofsleeve 20 is engaged within the proximal portion of collet 18 and collet18 is positioned onto the distal end of hand-piece 12. Pusher element 14is positioned within hand-piece 12, blades 16 are positioned on eitherside of sleeve 20 and ring clamp 22 is in place to secure sleeve 20within collet 18 and to further secure collet 18 onto hand-piece 12.Movement of pusher element 14 relative to hand-piece 12 moves blades 16toward the distal portion of the device and gently squeezes or urgeslens 50 forward and out of sleeve 20.

FIG. 8 is a perspective view of the distal portion of an assembleddevice 10. Here collet 18 is depicted with blades 16 extending fromlumen 47 of collet 18 with lens 50 having been squeezed or urged fromsleeve 20 by movement of pusher element 14 and blades 16 distally downthe length of sleeve 20.

In use, the physician can purchase the sleeve either alone orpreassembled with an implant, such as a lens already positioned withinthe sleeve. FIG. 9 illustrates a sleeve 60 with a lens 61, here anintraocular lens, positioned near first opening 62 at the proximal endof sleeve 60. A cap 63 or other sealing means, such as heat bonding, anadhesive, or the like is used to seal the proximal portion of sleeve 60(that portion including first opening 64). In FIG. 9, the second opening64 is also capped with a second cap 65 or otherwise sealed, such as byheat bonding, an adhesive, or the like. The sleeve alone or the sleevewith the lens is provided in sterile form to the physician and where theimplant is shipped in the sleeve, the sleeve preferably is filled, atleast in part, with a suitable friction reducing material such as alubricant or buffer, including a viscoelastic (i.e., an aqueoussuspension of water and up to 10% of a composition including, forexample, sodium hyaluronic acid, (i.e., HEALON), chondroitin sulfate, acellulose such as HPMC (hydroxypropylmethyl cellulose), or a combinationthereof) or a biocompatible liquid such as a variety of buffers known inthe art, including phosphate buffers, saline, and the like.

Where the sleeve is supplied alone without an implant, the surgeon canoptionally remove the caps or otherwise open the sleeve and introduce asuitable lubricant, by syringe or pipette, into one or both ends ofsleeve 60 before introducing the implant into the sleeve. Where asyringe or pipette is used, care is preferably taken to maintain theintegrity of the sleeve while the lubricant, buffer, or the like isadded. Next, the implant, such as a lens, and preferably an intraocularlens, is placed inside the first opening. If a forceps is used, care istaken to gently position the lens just inside the first opening oralternatively positioned directly into the tapered portion and into atleast part of the tubular portion of the sleeve. Optionally, the implantcan be deformed, such as by using a forceps, prior or concurrently withthe introduction of the implant into the sleeve. Where the implant is alens, the implant can be folded slightly (i.e., less than 20% of thediameter of the lens) or substantially (i.e., greater than 50% of thediameter of the lens) before the lens is introduced into the sleeve.Preferably, where the implant is a multi-piece intraocular lens withfilament haptics, the lens is introduced into the sleeve with one hapticpositioned in front of the lens and the second haptic trailing the lens.However, those skilled in the art will recognize that the lenses can beput into a sleeve in a variety of orientations without altering thescope of this invention. This invention is designed to accommodate avariety of implants, including a variety of lenses and a variety ofintraocular lenses including, but not limited to, single pieceintraocular lenses and three or more piece composite intraocular lensesthat employ a plurality of haptic supports.

Referring again to FIG. 2, preferably, once a lens 50 is positionedwithin the sleeve 20, a separate squeezing tool, such as tool 52 can beused to gently position the lens, at least in part, in the taperedportion 28 and preferably at least in part, past tapered portion 28 andinto the distal portion or tubular portion of sleeve 20, such asillustrated in FIG. 1. Squeezing tool 52 includes an elongate channel 54into which first opening 24 of sleeve 20 is introduced. Once in place,tool 52 is advanced toward the distal portion of sleeve 20 with sleeve20 passing in part, through channel 54 for a distance sufficient to urgelens 50 into position in sleeve 20 preferably past tapered portion 28.Sleeve 20 can then be assembled onto one of the devices of thisinvention. An alternative to the squeezing tool 52 is the use of thefingers to gently urge or otherwise nutate the implant through a sleeve.

The channel 54 of squeezing tool 52 can take on a variety of shapes.Preferably channel 54 is sufficiently long to accommodate the firstopening 24 of sleeve 20. In a preferred embodiment, the channel is anelongate slit extending through squeezing tool 52 and preferably thechannel is curved slightly. The channel 54 can be uniform in its heightor the channel can vary in height or shape of the channel to facilitatevarying dimensions of the implant. In a preferred embodiment, thechannel 54 of squeezing tool 52 is shaped in an upward-curving orupward-angled manner, as illustrated in FIG. 2, relative to theorientation of sleeve 20 when it is inserted in the squeezing tool 52 topromote the folding up of the lens in the sleeve such that when the lensis introduced into the eye, the edges of the lens open downward in theeye, much like a flower unfolding, to minimize trauma to the eye as thelens opens from its folded position. The folding of the lens is furtherassisted by the cross-sectional configuration of the sleeve, such as bya pleat or a “V” shaped cross-section. The actual squeezing tool cantake on a variety of geometries, for example in FIG. 2 is rectangular inshape. Circular, square, or ovoid shaped squeezing tools could also beused and one of ordinary skill in the art can imagine a variety ofshapes to the tool to facilitate its stabilization in the hand and toease use. The squeezing tool 52 or gentle urging with fingers overcomesthe damage to lenses that can be seen in devices that use a pushrod todirectly contact the lens and advance the lens through these devices.

In a preferred embodiment, as illustrated in FIG. 1, the implant ispositioned in the sleeve and the sleeve is positioned through collet 18.Collet 18 is then positioned onto pusher element 14 and ring clamp 22 isused to immobilize the sleeve 20 on hand-piece 12. FIG. 16 illustratesthe assembly of a sleeve 600 with an intraocular lens 602 into a collet604. In FIG. 16a the sleeve is preferably positioned in the collet 604with the second opening of the sleeve extending from the distal portionof the collet. The edges of the sleeve proximal to the first opening ofthe sleeve preferably extend at least to the edge of the slits 603 oneither side of the collet. Once the sleeve 600 is assembled in thecollet 604 a ring clamp 606 is positioned over the collet Next, the ringclamp is secured to the hand piece thereby securing the collet to thehand-piece and exerting pressure on the collet to compress the slits 603to immobilize the sleeve 600 on the device. As illustrated in FIG. 17a,a cross-section of the device through D—D of FIG. 17b, while assemblingthe ring clamp onto the hand-piece 608, blades 610 and 612 arepositioned on either side of the sleeve within the lumen of the colletas illustrated in FIG. 17c. The assembled device of FIG. 17 is providedin FIG. 17b.

Following appropriate incisions, the device is positioned in the eye,preferably such that a beveled portion of second opening 26 of sleeve 20(FIG. 2) is positioned downward. The pusher element 14 is advancedslowly toward the distal portion of the device and the lens, positionedin the sleeve such that the lens is folded upwards, is released into theeye with the folded edges opening downward, toward the eye as the lensis allowed to unfold.

Advantageously, the lens is oriented and folded consistently in sleeve20 through the use of one or a combination of the squeezing tool 52, thecross-sectional configuration of at least the tapered portion 28 ofsleeve 20, as illustrated in FIG. 3, a forceps and/or through the use offolding guides positioned on the internal surface of the lumen of collet18. Alternatively, the lens can be loaded and advanced past the taperedportion of the sleeve, in whole or in part through the use of forceps orother devices. A sleeve stabilizing device is provided in FIG. 19 toassist in loading an implant. This device is discussed infra.

There are other configurations for insertor devices within the scope ofthis invention. In another example, the device is a front loadinginsertor device. Referring now to FIG. 10a, which illustrates incross-section a preferred embodiment of a front-loading device forinsertion of an implant in the body. The device 100 includes ahand-piece 112 and a pusher element 114. The hand-piece 112 preferablyincludes an elongate body and a tapered portion 120 with distal opening121.

The pusher element 114 includes a sleeve holder 115. Sleeve holder 115could take a variety of forms such as a post, one or more blunt barbs,one or more grooves, or the like. Pusher element 114 further includesblades 122 mounted on distal block 124 in pusher element 114. Blades 122pass on each side of sleeve holder 115. The device further includes asleeve 116 affixed to sleeve holder 115. Sleeve 116 extends in a reverseorientation as compared to the sleeve orientation of FIG. 1. In FIG.10a, sleeve 116 is illustrated with a substantially tubular portion 117,a tapered portion 119, preferably at least one pleat 113 and a firstopening 118.

In this embodiment a lens or other implant is loaded into the sleeveusing the methods disclosed in association with FIG. 2 except that whatis the second opening in FIG. 2 is now affixed to sleeve holder 115 inFIG. 10a. A forceps can be initially used to position an implant infirst opening 118 or to position the lens completely in the tubularportion of the sleeve. A squeezing tool 52 or a forceps can then be usedto urge the implant just past the tapered portion 119 of the sleeve orat least toward what was the second opening of the sleeve of FIG. 2 andis now that portion of the sleeve affixed to sleeve holder 115 (FIG.10b).

Once the lens is loaded, that part of sleeve 116 including the firstopening 118 and the tapered portion 119 are separated from the portionof the sleeve including the lens. In some embodiments, the sleeve 116can be cut either with a sharp blade or scissors. Alternatively, aguillotine-type device can be used to sever the sleeve as a blunt-cut, abeveled cut, and the like.

Pusher element 114 is advanced toward tapered portion 120 of hand-piece112. With this movement, blades 122 advance or mobilize the lens, againby squeezing or urging, into the tapered portion 120 of hand-piece 112,as illustrated in FIG. 10b.

In yet another embodiment of this invention, the device is suppliedpre-assembled with a sleeve having a lens positioned therein. Preferablythe lens is supplied in a substantially unfolded state, but those ofordinary skill in the art will understand that with the development ofnew or different lens materials or configurations it may be possible tosupply the device with a sleeve and a lens, or other implant, deformedwithin the narrow portion of the sleeve, ready for insertion.

In an embodiment, illustrated in FIG. 11, a device 200, having ahand-piece 205 can be prepared in one piece or in two pieces. Asingle-piece hand-piece is illustrated in FIG. 11a. Here, the deviceincludes a hand-piece 205 and a pusher element 204. The hand-piece 205preferably includes an elongate body with a proximal flange 203, atapered portion 206 and a lumen 202. The hand-piece 205 includes adistal opening 208. The pusher element 204 includes a sleeve holder 210.Sleeve holder 210 can take a variety of forms, as described above.Pusher element 207 further includes blades 212 mounted on a proximalblock 214 of pusher element 207. Blades 212 pass on each side of sleeveholder 210.

A removable key 214 is positioned on pusher element 204. Sleeve 216 ispreferably provided with a lens 218 positioned therein. A first end ofsleeve 216 is affixed to sleeve holder 210 and a second opening 222 ofsleeve 216 is preferably sealed, such as with a cap 224 or seal.

In use, pusher element 204 is advanced toward tapered portion 206 ofhand-piece 205. With this movement, blades 212 advance the lens into thetapered portion 206 of hand-piece 205, as illustrated in FIG. 11b.

The pushing mechanism of FIG. 11 is a multi-step mechanism, here atwo-step pushing mechanism. A key 214 is removed from the pusher element204 after pusher element 204 has been partially advanced. Now pusherelement 204 can completely advance toward the distal portion of thedevice, blades 212 are free to advance the lens with pusher element 204and the lens is moved through sleeve 216, out of device 200 and into theeye, as illustrated in FIG. 11c. Multi-step pushing mechanisms areuseful for increasing control over the release of the lens from insertordevices.

In another embodiment of the inserters of this invention, the hand-pieceis prepared in multiple pieces, preferably in two pieces. This isparticularly useful where the insertor is provided preassembled with alens positioned in a sleeve. An example of this embodiment is providedin FIG. 12. Here the device 250 includes a hand-piece 252 that furtherincludes a distal portion 254 at the distal aspect of the hand-piece anda proximal hand-piece portion 256. The distal portion 254 includes atapered nose 258 including a distal opening 260. A septum 262 preferablytraverses the lumen of hand-piece 252 and includes a sleeve holder 264.Sleeve holder 264 is available to secure a sleeve 266 onto the device250. A pusher element 268 includes an elongate shaft to mate with thelumen of hand-piece 252 and at least one blade, and preferably twoblades 270 are preferably affixed thereto. The internal surfaces of thedistal portion 254 of hand-piece 252 can include external folding guides272. One example of these guides is provided by cross section in FIG.12b. The folding guides are termed external folding guides todifferentiate these guides from the cross-sectional configuration of thesleeve that provides internal folding guides for the lens (such as thepleats and the cross-sectional configurations of FIG. 3). The externalfolding guides 272 can take a variety of configurations and in apreferred embodiment, the cross section of distal portion 254 issubstantially rhomboid in cross-section with preferably two grooves tourge the lens into a folded confirmation. Other cross-sections to distalportion 254 are possible as are other folding guides. Other foldingguides are discussed in U.S. Pat. No. 5,275,604 to Rheinish et al.

Referring again to FIG. 12a, a lens 274 is preferably supplied insterile form in a capped 276 or otherwise sealed sleeve 266. Optionallythe sleeve can be supplied preloaded with a buffer compatible with theeye, or with a solution compatible with another portion of the bodyreceiving the implant. During assembly, the lens 274 is positioned inthe sleeve 266 and sleeve 266 is affixed to device 250 via sleeve holder264. Hand-piece 252 portions 254 and 256 are assembled on the devices tosurround the sleeve 266 and lens 274. Hand-piece 252 portions 254 and256 can be joined by a variety of means including, but not limited to,screw-type threads, grooves, notches, clamping mechanisms, snappingmechanisms, adhesives, and the like. Preferably, once assembled, thehand-piece 252 is not readily separable nor is the hand-piece preferablyseparable from the pusher element 268.

In use, cap 276 is removed from sleeve 266. Pusher element 268 isadvanced toward distal portion 254 of hand-piece 252 to advance blades270 behind lens 274 and advance lens 274 from the sleeve through opening260 and into the eye. Preferably, after use, device 250 is disposed. Itis noted that the insertor of FIG. 12 can also incorporate the two-partpushing element design of FIG. 11.

Sleeve 266 is preferably provided preassembled on the device with thelens in place and affixed to sleeve holder 264. Sleeve 266 preferablyincludes a suitable lubricant, a friction reducing material, implantstabilizer or buffer. Where a lubricant or buffer is not included withthe implant, the sleeve can be filled with a suitable lubricant orbuffer before use.

In another variation of this invention, the pusher element can beadvanced using a threaded mechanism, such as screws, rack and pinion, orany other mechanism. These mechanisms can provide added control when thelens is being advanced by the blades.

In another preferred device 300 according to this invention (see FIG.13), a hand-piece 312 preferably includes an elongate body having aproximal end 314 and a distal end 316. The distal end 316 preferablyincludes a tapered portion 318 and a canal 320 communicating with alumen 322. The canal 320 also communicates with a slot 324 that ispositioned proximal to canal 320 on hand-piece 312. A hole 326 ispositioned from slot 324 to an external aspect of hand-piece 312 and isadapted to receive a sleeve clamping thumbscrew 327. Sleeve 328 is aflexible, compressible sleeve with a first opening 330, a second opening332 and a tapered portion 334 positioned therebetween. In a preferredembodiment, the second opening is preferably beveled. An implant, suchas a lens, is introduced into sleeve 328 and advanced toward the distalportion of the sleeve either using the squeezing tool 52, as illustratedin FIG. 2, or by gently urging the implant into the sleeve, past thetapered portion using a forceps, or the like.

Once sleeve 328 is loaded with an implant, the sleeve is positioned inhandpiece 312. The second opening 332 of sleeve 328 is passed throughlumen 322 and the first opening 330 of the sleeve 328 is positioned intoslot 324. Sleeve clamping thumbscrew 327 is tightened to immobilizesleeve 328. In one aspect of this embodiment, a squeezing blade assembly336 including at least one blade, and preferably two blades 338 areconnected to a thumb-engaging portion 340. The squeezing blade assembly336 is positioned on either side of sleeve 328 and before thumb-engagingportion 340 is mobilized, blades 338 are positioned just proximal tolens 342. Movement of the thumb-engaging portion 340 along the axis ofhand-piece 312 toward the distal end 316 of device 300 results in theegress of lens 342 from sleeve 328. In an alternative embodiment of thedevice of FIG. 13, the thumb screw 327 is replaced with a ring clamp toimmobilize the sleeve 328. Thumb knobs can be added to the squeezingblade assembly as desired.

In yet another embodiment, the sleeve can be used separately as aninsertor without using the hand-piece portion of this invention. Forexample, a sleeve, such as illustrated in FIG. 2 is loaded with animplant, such as a lens, as provided above. The sleeve itself can beused to directly deliver the lens by clamping a portion of first opening24 of the sleeve with a forceps or suitable hemostat-type device. Inthis embodiment a pushrod, such as a small cylindrical bar, can beintroduced into the sleeve after the implant has been inserted andpositioned in the sleeve by squeezing or urging the implant towards thedistal end. The implant is mobilized using direct force applied to theimplant by the pushrod to introduce the implant into the body.Alternatively, a squeezing tool, such as that illustrated in FIG. 2, ora modification of the squeezing tool (for example, with an added handle,or the like) can be used to position the lens in the sleeve or asqueezing tool can be use to advance the implant into the taperedportion of the sleeve, toward the second opening of the sleeve and pastthe second opening and into the body. In a further embodiment, theimplant is advanced through the sleeve using fingers to gently urge thelens by nutating and/or gently pinching the sleeve behind the implant.In yet a further embodiment, the sleeve can be rolled from the firstopening 24 to the second opening to advance the lens or another implantthrough a sleeve. In some of these embodiments, a squeezing motion isused to advance the lens, at least in part, through the sleeve. Theability of the sleeve to be squeezed through a squeezing device,manipulated by fingers to advance an implant or to roll up a portion ofthe sleeve to advance the implant also speaks to the nature of thesleeve material. The flexible, compressible, malleable sleeve isprepared from a material that permits ready manipulation of the sleeveas described herein.

As noted above, the devices of this invention can position implants inthe eye or elsewhere in the body. For example, in a preferredembodiment, illustrated in FIG. 14a, the implant is a lens 450. The lensis advanced using blades 416 on sleeve 420 to squeeze a lens 450 intothe eye, generally illustrated as 452. FIG. 14b is a cross section ofthe eye with a cornea 422, a natural lens 424 and the distal portion 410of a device according to this invention including blades 416 and asleeve 420 to advance a lens into the eye. The lens is not necessarilyan intraocular lens, but the lens can take the form of an implantablecontact lens (ICL) shown in FIG. 14b positioned just anterior to thenatural lens 424. Alternatively, the devices of this invention can beused to implant a flexible contact lens onto the surface of the cornea,the device can be used to introduce devices to treat glaucoma or toimplant a variety of flexible, solid implants elsewhere in the body.

In several embodiments of this invention, the invention provides a meansfor compressing a sleeve to advance an implant from the sleeve into aportion of a body. FIG. 15 is an enlarged partial cross-sectional viewof the interface between one means for compressing a sleeve inaccordance with the present invention. The sleeve 520 includes two sidewalls 520 a and 520 b. At least a portion of the side walls 520 a and520 b is compressed in the preferred embodiment by blades 516 a and 516b as depicted in FIG. 15. Those of skill in the art will, however,understand that many other means for compressing sleeve 520 could besubstituted for the disclosed blades.

The compressed portion of the sleeve 520 is then advanced in thedirection of arrow 510 towards the implant 550 located between sidewalls 520 a and 520 b in sleeve 520. As a result, the blades 516 alsofunction as one preferred embodiment of the means for advancing thecompressed portion of sleeve 520 towards the distal end of sleeve 520.Those of skill in the art will, however, understand that many othermeans for advancing the compressed portion of sleeve 520 could besubstituted for the disclosed blades. It is the gentle, squeezing actionof sleeve 520 on implant 550 that provides the ability of the presentintention to gently deliver an implant in contrast to the known methods.

Those of ordinary skill in the art will recognize that this device hasbeen described by way of using a lens. For other implants, the sleeveconfiguration can be varied somewhat. For example, while the sleevewould preferably still include a first opening and a second opening, thesleeve may not need a tapered portion, particularly where deformation ofthe implant prior to insertion is not necessary. Moreover, alsodepending on a particular insertion application, the dimensions of thedevice and the dimensions of an incision size can change for aparticular application. The cross-section of the sleeve can be narroweror wider, the blade length, sleeve length, hand-piece length can beadjust by ordinary skill in the art to accommodate a variety ofimplants.

Those of skill in the art will realize that although the devicesdescribed in this invention are operated using manual force, similardevices can be prepared using pneumatic, servo-mechanisms includingelectrical and hydraulic forces, extended flexible cable devices, suchas via a foot pedal, or the like without detracting from the scope ofthis invention.

In one embodiment of this invention, the device is supplied in kit formwith an insertor, such as insertor 10 (FIG. 1), a sleeve, in one or twopieces, either empty or already containing the implant and optionally asqueezing tool such as squeezing tool 52. The implant can be suppliedwith the device or purchased separately. Preferably the device is usedto implant a foldable lens and preferably the foldable lens is anintraocular lens.

In another aspect of this invention, the invention includes a sleevesupporting device such as a sleeve holder 650 as illustrated in FIG. 19.The sleeve holder 650 is preferably prepared from a substantially rigidmaterial such as a plastic, including thermoplastic polymers, as well asacrylics, hard silicones, nylon, rubber, and the like. In a preferredembodiment the sleeve holder 650 is prepared from a sufficiently clearmaterial to permit visualization of the implant in the sleeve when thesleeve is in position in the holder. The sleeve holder includes ahollowed portion that is slightly larger but generally and preferablyconforms in shape to the shape of sleeve 652 or another sleeve,according to this invention. The sleeve of FIG. 19 includes a firstopening 654 and a second opening 656. The first opening 654 ispreferably larger than second opening 656 and preferably the diameter offirst opening 654 is from about 4.5 mm to about 10 mm and the diameterof the second opening 656 is from about 1.5 mm to about 4 mm. Apreferred length of the holder is from about 2 cm to about 4 cm. Thesleeve holder adds support to the flexible deformable sleeve duringinsertion of an implant, such as an intraocular lens 658 into thesleeve. The sleeve holder can take any of a variety of shapes andpreferably the shape and size of the holder permit it to be held in onehand while inserting an implant into a sleeve in the holder with theother hand. In FIG. 19, the holder is rectangular in shape, but those ofordinary skill in the art will recognize that a variety of holder shapesand sizes can be prepared to accommodate sleeves in view of thisdisclosure. Importantly, the pleats 38 in sleeve 20 of FIG. 2 areoptional when a sleeve holder such as sleeve holder 650 is used. Thecombination of a sleeve of this invention with a sleeve holder forms animplant loading system of this invention.

In use, the sleeve is positioned in the block before or afterlubricating the sleeve with a suitable friction-reducing agent orbuffer. The intraocular lens 658 is inserted into first opening 654using a forceps 660, fingers, or the like. The lens is urged into thefirst opening and is positioned preferably past the tapered portion 662of sleeve 652 and at least partially into the tubular portion 655 of thesleeve. The sleeve is preferably able to distend or stretch toaccommodate the additional bulk of the forceps when the forceps isintroduced into the sleeve with the implant. Optionally, the implant canbe deformed slightly to encourage folding in a desired direction whenthe implant is introduced into the sleeve, using for example, lateralpressure while introducing the lens into the tapered portion and into662 at least a part of the tubular portion. The forceps 660 is removedfrom the first opening 654 and the sleeve 652 is removed from holder650. The sleeve holder is preferably reusable and can optionally bedisposable or sterilizable such as by autoclaving, ethylene oxide, orultraviolet light.

Not only is the holder capable of being sterilized, but other componentsof this invention including the hand-pieces, ring clamps, collets,pusher-elements, and the like can be sterilized for reuse.

The invention also relates to a kit comprising a sleeve of thisinvention, an implant, such as an intraocular lens, a corneal implant oranother implant according to this invention. Optionally, the kitincludes a holder for the sleeve, such as provided in FIG. 19 andoptionally the kit includes an insertor device according to thisinvention. Further the elements of the kit are packing in a tray orpackage suitable for shipping.

FIG. 18 illustrates an additional insertor embodiment that employs aflexible, deformable sleeve of this invention together with a pushrod tomobilize an implant from an insertor into a portion of the body. In FIG.18a, an insertor 700 includes a flexible sleeve 702, a collet 704, and aring clamp 706. A hand-piece 708 includes a pusher-element 710 or othermeans for mobilizing a pushrod 712. The pushrod 712 is preferablyrounded at the tip 714 to minimize trauma to the implant when theimplant is mobilized in the sleeve 702 but the pushrod could also beflattened or grooved. The pushrod 712 is preferably prepared from eitherthe same or similar material as the hand piece or alternatively preparedfrom stainless steel, TEFLON, acrylic, vinyl, polysulfone, or the like.

To assemble, the sleeve 702, collet 704 and ring clamp 706 can beassembled as described in regard to FIG. 16. The pushrod 712 preferablyextends from the hand-piece sufficiently that it can be positionedwithin the first opening of the sleeve 702 as the ring clamp 706 isposition and affixed to the hand-piece 708. At least one indexingextension 713 preferably extends from the distal portion of thehand-piece to key or mate with the proximal portion of the collet (asillustrated in the proximal portion of the collet of FIG. 16). Theextensions prevent rotation of the collet relative to the hand-piece asthe ring clamp is secured to the hand-piece. The ring clamp 706 securesthe collet to the device and provides a clamping force to immobilizesleeve 702 between slits 716 of collet 704.

In another variation, the sleeve with an implant is positioned over thepushrod 712. Where an intraocular lens is used, care is taken to alignthe pushrod with the body of the lens so that the haptics are free tomove within the sleeve. Next, collet 704 is placed over the sleeve andpositioned onto hand-piece 708 using extensions 713. The ring clamp 706is next positioned onto the device.

The assembled device is provided in FIG. 18b and the distal end ofcollet 704 for the pushrod device is preferably illustrated in FIG. 4a.A cross-section of the device through E—E of FIG. 18b is illustrated inFIG. 18c. Here ring clamp 706 surrounds the proximal portion of collet704. Sleeve 702 is positioned within the lumen 718 of collet 704 withpushrod 712 positioned within sleeve 702. Ring clamp 706 provides aclamping force to immobilize sleeve 702 within the device 700. The ringclamp 706, the screw 327 of FIG. 17 and other pressure fit elements arecontemplated to immobilize the sleeve of this invention in the inserter.

Once assembled, an incision into the body is prepared and the sleeve 702is positioned in or adjacent to the incision. The pushrod 710 is gentlyactivated to advance the pushrod toward the distal portion of thedevice, thereby mobilizng the implant in the sleeve 702 and from thesleeve into the body. While either the blade embodiment or the pushrodembodiment will function with the flexible, deformable sleeves of thisinvention, the blades may be better suited for more fragile implants.Advantageously, the pushrod device in combination with the sleeve ofthis invention requires little force to mobilize an implant so that thelikelihood of damaging the implant with the pushrod is low.

In another aspect of this invention, the invention relates to a methodfor making a sleeve of this invention. A variety of methods areavailable in the art for making the sleeves of this invention from avariety of flexible, distendable, compressible materials. These methodsinclude, but are not limited to, injection molding and pressing orcompressive forces to form the sleeve from existing materials.

In a preferred embodiment, a compressive force is used to compress anddistend a flexible and distendable material to form a sleeve. In apreferred method, ETFE or PTFE tubing is subjected to a squeezing andcompressive force such as a hydraulic or screw-jack press to form,squeeze and flatten the tubing into the widened first opening of thesleeve so that the width is wider than the initial tubing diameter andto form the tapered portion of the sleeve. Heat can be added to thecompressive force to ease compression, for example, for higher tensilestrength plastics. Preferred temperatures should be below the meltingtemperature of the tubing and preferably for PTFE tubing less than about232° C. However, in a preferred embodiment the press does not include aheat source and the press uses cold flow squeezing to flatten and expandthe PTFE or ETFE tubing to form a wider implant loading zone (i.e, thefirst opening of the sleeve) relative to the tubing diameter.

Referring now to FIG. 20, and following the direction of arrow 801, FIG.20 illustrates a preferred method for producing the sleeves of thisinvention using preformed tubing 800, where the tubing 800 is malleableand substantially transparent to permit visualization of an implant whenpositioned therein and where the tubing is suitable to distension andcompression.

The tubing 800 is positioned between a press, preferably comprising twocompressive surfaces 802 and 804. Tubing 800 is preferably extrudedtubing and preferably PTFE or ETFE. Preferred PTFE tubing is about 2.5mm in diameter with a preferred wall thickness of about 0.15 mm butthose of ordinary skill in the art will recognize that a variety ofsizes of tubing and a variety of compressive forces can be used toprepare sleeves of this invention in a variety of sizes and wallthicknesses without undue experimentation. The tubing is subjected to acompressive force sufficient to permanently flatten or distend andcompress the tubing. A preferred distended tubing shape is provided inFIG. 20 as distended tubing portion 806. Preferred distension andcompressive forces will depend on the tubing material but are preferablybetween about 1,000 psi to about 25,000 psi and more preferably fromabout 5,000 psi to about 10,000 psi. Preferably the force is appliedperpendicular to the tubing. Referring again to compressive surfaces 802and 804, preferably at least one of the compressive surfaces includes asloping portion 808 that slopes away from at least one of thecompressive surfaces. The angle of the sloping portion relative to thecompressive surface can vary but is preferably at least 0.5° and in apreferred embodiment is about 1°. Preferred post-compression wallthicknesses for 2.5 mm PTFE tubing are about 0.01 mm to about 0.10 mmwith a preferred post-compression wall thickness of about 0.08 mm.Preferably the post-compression wall thickness of the sleeve is lessthan two-thirds and preferably about one-half of the original wallthickness of the non-compressed tubing and is preferably furtherdistended at least 1.6 of the original diameter of the tubing and morepreferably about 3 times the diameter and preferably from about 2 toabout 4 times the original diameter of the tubing

Following application of a compressive force, the distended tubingportion 806 is cut, such as with a cutting blade 810 or another device.In addition, the tubing is further cut in a non-distended region, ifneeded, as illustrated using cutting blade 812. Cutting blade 812 can beangled, if desired, to produce a beveled effect. Advantageously, usingthis method, each region of distended tubing can be used to prepare twosleeves 814 and 816 as illustrated in FIG. 20. The mechanics behind thecompressive surfaces can vary such that a mechanized press, a hydraulicpress, a hand cranked press or the like can be used, as suited to aparticular application. Further, the sleeves can be preparedindividually, or, as illustrated in FIG. 20 in a production line. Asdiscussed above, the final length of the sleeve, the shape of thedistended portion and the length of the non-distended portion as well asthe grade of the taper of the sleeve can vary depending on thedimensions of the insertor.

It will be appreciated by those skilled in the art that while theinvention has been described above in connection with particularembodiments and examples, the invention is not necessarily so limitedand that numerous other embodiments, examples, uses, modifications anddepartures from the embodiments, examples and uses may be made withoutdeparting from the inventive scope of this application.

What is claimed is:
 1. A device for introducing an implant into the bodycomprising: a flexible compressible sleeve wherein the sleeve comprisesa first opening and a second opening and a lumen extending through thesleeve, wherein the sleeve is prepared from a non-opaque material andwherein the width of the first opening is larger than the width of thesecond opening; and a hand-piece capable of mobilizing the implant andimmobilizing the sleeve, wherein the hand-piece comprises: at least oneblade to mobilize the implant by squeezing the sleeve; and a pressurefit element to immobilize the sleeve in the hand-piece, wherein thepressure fit element is a collet or a screw.
 2. The device of claim 1wherein the implant is a lens.
 3. The device of claim 2 wherein theimplant is an intraocular lens.
 4. The device of claim 1, wherein thesleeve is provided with a buffer.
 5. A device for introducing an implantinto the body comprising: a flexible compressible sleeve wherein thesleeve comprises a first opening and a second opening and a lumenextending through the sleeve, wherein the sleeve is prepared from anon-opaque material and wherein the width of the first opening is largerthan the width of the second opening; and a hand-piece capable ofmobilizing the implant and immobilizing the sleeve, wherein thehand-piece further comprises a collet or a screw to immobilize thesleeve in the hand-piece.
 6. The device of claim 5 wherein the implantis a lens.
 7. The device of claim 5 wherein the implant is anintraocular lens.
 8. The device of claim 5 wherein the hand-piececomprises a pushrod positioned within the sleeve to mobilize theimplant.
 9. The device of claim 8 wherein the push rod has a roundedtip.
 10. The device of claim 5, wherein the sleeve is provided with abuffer.
 11. A device for introducing an implant into the bodycomprising: a flexible compressible sleeve wherein the sleeve comprisesa first opening and a second opening and a lumen extending through thesleeve, wherein the sleeve is prepared from a non-opaque material andwherein the width of the first opening is larger than the width of thesecond opening; and a hand-piece capable of mobilizing the implant andimmobilizing the sleeve, wherein the hand-piece comprises: at least oneblade to mobilize the implant by squeezing the sleeve; and a collet or ascrew to immobilize the sleeve in the hand-piece.